The changes in hazard classification and product notification procedures of the new European CLP and Cosmetics Regulations

Groot, Ronald de; Brekelmans, Pieter; Herremans, Joke M. M.; Meulenbelt, Jan

doi:10.3109/15563650903376097

Cited by 10 publications

(12 citation statements)

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“…this prediction model could be very suitable to quickly screen for the most potent sensitizers. Importantly, the discrimination between two classes of sensitizers (weak and strong) coincides with the European Classification, Labeling and Packaging of substances (CLP) regulation, which is harmonized with the United Nations Globally Harmonized System (GHS) of Classification and Labeling of Chemicals (UN-GHS) (see review de Groot et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

International ring trial of the epidermal equivalent sensitizer potency assay: reproducibility and predictive capacity

Teunis

2014

ALTEX

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Summary This study describes the international ring trial of the epidermal-equivalent (EE) sensitizer potency assay. This assay does not distinguish a sensitizer from a non-sensitizer, but may classify known skin sensitizers according to their potency. It assesses the chemical concentration resulting in 50% cytotoxicity (EE-EC50)or the 2-fold increase in Abbreviations: AOO, acetone:olive oil (4:1); BD, broad dose; EE, epidermal equivalent; EC 50 , chemical concentration in mg/ml that results in a decrease in cell viability to 50% compared to vehicle treated epidermal equivalents; DiSFeB, Dipartimento di Scienze Farmacologiche e Biomolecolari, Milan University, Milan; DMSO, 1% dimethylsulfoxide; DSA 05 , chemical dose per skin area in µg/cm 2 leading to a sensitization incidence of 5% in the human tested population; FD, fine dose; GPMT, Guinea Pig Maximization Test; HU, University of Applied Sciences, Utrecht; HRIPT, Human Repeat Insult Patch Test; IL-1α 2x , Chemical concentration in mg/ml resulting in a 2-fold increase in IL-1α release into culture supernatant of EE compared to supernatant of vehicle-exposed EE; LLNA, Local Lymph Node Assay; NOEL, human threshold level (no observed effect level) expressed in µg/cm 2 ; OECD, Organisation for Economic Co-operation and Development; SOP, standard operating procedure; VUMC, VU University Medical Center, Amsterdam

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Section: Discussionmentioning

confidence: 99%

International ring trial of the epidermal equivalent sensitizer potency assay: reproducibility and predictive capacity

Teunis

2014

ALTEX

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“…This evaluation mainly considers irritation and contact allergy, while other possible effects on human health or the environment need not be assessed [54][55][56]. Considering the required administration of vast amounts of data for all chemicals, better coordination of these regulations would go a long way to promote effective PCP risk management [57]. Ingredients of PCPs are good examples to show how difficult it is to regulate chemicals through legal instruments such as REACH and respective product regulations.…”

Section: Rc Mechanisms In General For Pcpsmentioning

confidence: 99%

“…Step one requires that the issue is well understood by Member States Competent Authorities based on the scientific data in relation to PCP ingredients, although the data availability is not as straightforward as for other chemicals [54,57]. In steps two to four, there is a big discrepancy between the recommendations by ECHA and the actual situations in the EU and SA, illustrating that PCPs RC is not in line with ECHA recommendations.…”

Section: Examples Of Ingredient Lists From the Eu And The Usamentioning

confidence: 99%

‘Read this and be safe!’ Comparison of regulatory processes for communicating risks of personal care products to European and South African consumers

Klaschka

Rother

2013

Environ Sci Eur

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Background: Most personal care products (PCPs) contain hazardous ingredients, but current legislation in the European Union (EU) and South Africa (SA) does not require these to be labelled as hazardous products. Instead, ingredients must only be listed on containers to inform consumers of potential hazards. We assessed whether current legal strategies provide the means for effective risk communication (RC) mechanisms for PCPs in order to protect consumers' health and the environment. Results and conclusions: RC strategies used in developed countries are not necessarily better compared to developing countries despite the existence of extensive legislation in the former. Socio-cultural factors, scientific literacy and language differences are key reasons why the current ingredient lists on PCP labels are not an effective RC strategy. The assumption is that consumers will interpret the risks of these ingredients by conducting a risk assessment for their personal context. Realistically, the following risk mitigation measures should be implemented in developed and developing countries to reduce the public's potential exposures to hazardous substances: substitute hazardous ingredients with less hazardous; provide accessible mechanisms for consumers to comprehend RC measures; delete the exception clause in the EU Regulation on Classification, Labelling and Packaging (CLP); apply clear mandatory labels where PCPs health risks are clearly illustrated; and increase enforcement of legislation. The high incidence of fragrance allergies caused by PCPs is one example illustrating how current legal measures in the EU and SA fail to protect consumers and the environment from hazardous exposures. Therefore, efforts must be made to improve legally required RC measures.

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“…Poisons Centres will be confronted with a new hazard classification according to the CLP Regulation, introducing new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard(H)-statements and Precautionary(P)-statements as hazard communication elements. 7 Especially relevant for PCs are the new P-statements with the phrase: ‘Call a POISON CENTER or doctor/physician'. In countries where the PCs are only open to inquiries from the health service and not from the general public (like in the UK and in the Netherlands) such statements on a product label could increase the inquiries from the general public and so have consequences for the poisons information supply in these countries.…”

Section: Clp Regulationmentioning

confidence: 99%

Implications of the new EU legislation on chemicals for Poisons Centres

Groot

Brekelmans

Meulenbelt

2011

Clinical Toxicology

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The changes in hazard classification and product notification procedures of the new European CLP and Cosmetics Regulations

Cited by 10 publications

References 1 publication

International ring trial of the epidermal equivalent sensitizer potency assay: reproducibility and predictive capacity

International ring trial of the epidermal equivalent sensitizer potency assay: reproducibility and predictive capacity

‘Read this and be safe!’ Comparison of regulatory processes for communicating risks of personal care products to European and South African consumers

Implications of the new EU legislation on chemicals for Poisons Centres

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